Skip to content
← Full study record

NCT01828099 · OUTCOME

Overall Survival (OS)

LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer · Source last updated 2025-01-16

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From date of randomization to date of death due to any cause, up to approximately 120 months

What was measured

OS defined as time from date of randomization to date of death due to any cause. If the patient was alive at the date of the analysis cut-off or lost to follow-up, then OS was censored at the last contact date prior to data cut-off date. The distribution of OS was estimated using the KM method.

Analysis population: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization

Groups in this outcome

Ceritinib

Ceritinib administered continuously through oral dosing at a dosage of 750 mg once daily in fasted state

Chemotherapy

Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance)

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Ceritinib189
Chemotherapy187

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ceritinib62.9Not reported44.277.6Not reported
Chemotherapy40.7Not reported28.554.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        44.2
        upper Limit
        77.6
        value
        62.9
      2. group Id
        OG001
        lower Limit
        28.5
        upper Limit
        54.5
        value
        40.7
denoms
  1. counts
    1. group Id
      OG000
      value
      189
    2. group Id
      OG001
      value
      187
    units
    Participants
description
OS defined as time from date of randomization to date of death due to any cause. If the patient was alive at the date of the analysis cut-off or lost to follow-up, then OS was censored at the last contact date prior to data cut-off date. The distribution of OS was estimated using the KM method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Ceritinib administered continuously through oral dosing at a dosage of 750 mg once daily in fasted state
    id
    OG000
    title
    Ceritinib
  2. description
    Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance)
    id
    OG001
    title
    Chemotherapy
param Type
MEDIAN
population Description
The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization
reporting Status
POSTED
time Frame
From date of randomization to date of death due to any cause, up to approximately 120 months
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice